Label: VARDENAFIL tablet, orally disintegrating

2 DOSAGE AND ADMINISTRATION

5.1 Cardiovascular Effects

This list is not complete and many other drugs may affect vardenafil. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

RedBox Rx Reviews

If you are a consumer or patient please visit this version. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS.VARDENAFIL HYDROCHLORIDE orally disintegrating tabletsInitial U.S. Approval: 2003RECENT MAJOR CHANGESWarnings and Precautions (5.2) 4/2023INDICATIONS AND USAGE• Vardenafil hydrochloride orally disintegrating tablets are phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. (1).DOSAGE AND ADMINISTRATION• Vardenafil hydrochloride orally disintegrating tablets are not interchangeable with vardenafil 10 mg film-coated tablets (LEVITRA). 2.1 GeneralVardenafil hydrochloride orally disintegrating

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tablets are available in 10 mg orally disintegrating tablets.

What It Contains

Vardenafil hydrochloride orally disintegrating tablets provide higher systemic exposure compared to vardenafil 10 mg film-coated tablets (LEVITRA). (2.1)• Vardenafil hydrochloride orally disintegrating tablets are taken as needed, orally, approximately 60 minutes before sexual activity. (2.1)• The maximum recommended dosing frequency is one tablet per day. (2.1)• Vardenafil hydrochloride orally disintegrating tablets should be placed on the tongue where it will disintegrate. (2.1)• Vardenafil hydrochloride orally disintegrating tablets may be taken with or without food.

Professional resources

(2.2)DOSAGE FORMS AND STRENGTHS• Vardenafil hydrochloride orally disintegrating tablets 10 mg: White to off white, round, orally disintegrating tablets (not scored) (3)CONTRAINDICATIONSWARNINGS AND PRECAUTIONS• Cardiovascular Effects: Patients should not use vardenafil hydrochloride orally disintegrating tablets if sex is inadvisable due to cardiovascular status. (5.1)• Strong and Moderate CYP3A4 Inhibitors: Do not use vardenafil hydrochloride orally disintegrating tablets in patients taking strong or moderate CYP3A4 inhibitors. (5.2, 7.2)• Risk of Priapism: In the event that an erection lasts more than 4 hours, the patient should seek immediate medical assistance. (5.3)• Effects on the Eye: Patients should stop use of vardenafil hydrochloride orally disintegrating tablets and seek medical attention in the event of sudden loss of vision in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION). Vardenafil hydrochloride orally disintegrating tablets should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Vardenafil hydrochloride orally disintegrating tablets are not

Vardenafil dosing information

(7.2)USE IN SPECIFIC POPULATIONSSee 17 for PATIENT ed tablets COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 7/2025 Warnings and Precautions (5.2) 4/2023 • Vardenafil hydrochloride orally disintegrating tablets are phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. • Vardenafil hydrochloride orally disintegrating tablets are not interchangeable with vardenafil 10 mg film-coated tablets (LEVITRA). • Vardenafil hydrochloride orally disintegrating tablets are taken as needed, orally, approximately 60 minutes before sexual activity. • The maximum recommended dosing frequency is one tablet per day. • Vardenafil hydrochloride orally disintegrating tablets should be placed on the tongue where it will disintegrate.

Pulmonary Arterial Hypertension (Orphan)

• Vardenafil hydrochloride orally disintegrating tablets may be taken with or without food. • Vardenafil hydrochloride orally disintegrating tablets 10 mg: White to off white, round, orally disintegrating tablets (not scored) (3) • Cardiovascular Effects: Patients should not use vardenafil hydrochloride orally disintegrating tablets if sex is inadvisable due to cardiovascular status. • Strong and Moderate CYP3A4 Inhibitors: Do not use vardenafil hydrochloride orally disintegrating tablets in patients taking strong or moderate CYP3A4 inhibitors. • Risk of Priapism: In the event that an erection lasts more than 4 hours, the patient should seek immediate medical assistance. • Effects on the Eye: Patients should stop use of vardenafil hydrochloride orally disintegrating tablets and seek medical attention in the event of sudden loss of vision in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION). interchangeable with vardenafil 10

• Vardenafil is ineffective without sexual arousal.
• It does not protect against sexually transmitted infections.
• Avoid excessive mental or physical exertion while on medication.
• Consult a healthcare professional if unsure about interactions.
• Don't take vardenafil if you've had recent heart attack.
• Use with caution if you have a bleeding disorder.
• Medication may cause a temporary drop in blood pressure.
• Avoid using if you have a known hypersensitivity.
• The pill should be taken as part of a treatment plan.
• Keep track of how you respond to the medication.

mg film-coated tablets (LEVITRA).

• Some users may experience mild flickering vision episodes.
• The efficacy of vardenafil varies between individuals.
• The medication is available in various dosage forms.
• Always follow the specific instructions provided.
• Avoid taking vardenafil with high-fat meals to speed absorption.
• Do not take vardenafil if allergic to its ingredients.
• The drug may cause a temporary burning sensation.
• Use caution in patients with a history of priapism.
• Avoid combining vardenafil with certain herbal supplements.
• Consult your doctor about any ongoing health treatments.

Vardenafil hydrochloride orally disintegrating tablets

Advice Point	Explanation
Take on an empty stomach	Food, especially high-fat, may delay absorption
Do not combine with nitrates	Can cause severe hypotension
Avoid alcohol consumption	Can impair effectiveness and cause side effects
Follow prescribed dosage	To minimize side effects and interactions

provide higher systemic exposure compared

What can cause erectile dysfunction?

Patients with a “crowded” optic disc may also be at an increased risk of NAION. (5.4, 6.2)• Sudden Hearing Loss: Patients should stop vardenafil hydrochloride orally disintegrating tablets and seek medical attention in the event of sudden decrease or loss in hearing. (5.5, 6.2)• Alpha-Blockers: Caution is advised when PDE5 inhibitors are coadministered with alpha-blockers. In some patients, concomitant use of these two drug classes can lower blood pressure significantly leading to symptomatic hypotension (for example, fainting). In patients taking alpha-blockers, do not initiate vardenafil therapy with vardenafil hydrochloride orally disintegrating tablets.

Erectile Dysfunction

(2.4, 5.6)• QT Prolongation: Patients with congenital QT syndrome or taking class IA or III antiarrhythmics should avoid using vardenafil hydrochloride orally disintegrating tablets. (5.7, 12.2)• Phenylketonurics: Each vardenafil hydrochloride orally disintegrating tablet contain 1.403 mg phenylalanine per tablet, which could be harmful for patients with phenylketonuria. (5.12)ADVERSE REACTIONSAdverse reactions reported by ≥ 2% of patients treated with vardenafil hydrochloride orally disintegrating tablets: Headache, flushing, nasal congestion, dyspepsia, dizziness, back pain. (6.1)To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or INTERACTIONS• Vardenafil hydrochloride orally disintegrating tablets can potentiate the hypotensive effects of nitrates, alpha-blockers, and antihypertensives. (7.1)• Do not use vardenafil hydrochloride orally disintegrating tablets with moderate or strong CYP3A4 inhibitors as coadministration will result in significant increases in plasma vardenafil concentrations. to vardenafil 10 mg film-coated

Other Comments

To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or • Vardenafil hydrochloride orally disintegrating tablets can potentiate the hypotensive effects of nitrates, alpha-blockers, and antihypertensives. • Do not use vardenafil hydrochloride orally disintegrating tablets with moderate or strong CYP3A4 inhibitors as coadministration will result in significant increases in plasma vardenafil concentrations. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE2 DOSAGE AND ADMINISTRATION2.1 General2.2 Use with Food2.3 Use in Special Populations2.4 Concomitant Medications3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS4.1 Nitrates4.2 Guanylate Cyclase (GC) Stimulators5 WARNINGS AND PRECAUTIONS5.1 Cardiovascular Effects5.2 Potential for Drug Interactions with Strong or Moderate CYP3A4 Inhibitors5.3 Risk of Priapism5.4 Effects on the Eye5.5 Sudden Hearing Loss5.6 Alpha-Blockers5.7 Congenital or Acquired QT Prolongation5.8 Hepatic Impairment5.9 Renal Impairment5.10 Combination with Other Erectile Dysfunction Therapies5.11 Effects on Bleeding5.12 Phenylketonurics5.14 Sexually Transmitted Disease6 ADVERSE REACTIONS6.1 Clinical Studies Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS7.1 Potential for Pharmacodynamic Interactions with Vardenafil Hydrochloride Orally Disintegrating Tablets7.2 Effect of Other Drugs on Vardenafil7.3 Effects of Vardenafil on Other Drugs8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.4 Pediatric Use8.5 Geriatric Use8.6 Hepatic Impairment8.7 Renal Impairment10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility14 CLINICAL STUDIES14.1 Other Vardenafil Clinical Trials Using Film-Coated Tablets16 HOW SUPPLIED/STORAGE AND HANDLING16.1 How Supplied16.2 Recommended Storage17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed. Sections or subsections omitted from the full prescribing information are not listed. tablets (LEVITRA) [see Clinical Pharmacology (12.3).

2.2 Use with Food

• Sudden Hearing Loss: Patients should stop vardenafil hydrochloride orally disintegrating tablets and seek medical attention in the event of sudden decrease or loss in hearing. • Alpha-Blockers: Caution is advised when PDE5 inhibitors are coadministered with alpha-blockers. • QT Prolongation: Patients with congenital QT syndrome or taking class IA or III antiarrhythmics should avoid using vardenafil hydrochloride orally disintegrating tablets. • Phenylketonurics: Each vardenafil hydrochloride orally disintegrating tablet contain 1.403 mg phenylalanine per tablet, which could be harmful for patients with phenylketonuria. Adverse reactions reported by ≥ 2% of patients treated with vardenafil hydrochloride orally disintegrating tablets: Headache, flushing, nasal congestion, dyspepsia, dizziness, back pain.